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A clinical trial of Gingkco Biloba Extract in patients with intermittent claudication.

Thirty-seven patients with stage 2 peripheral vascular disease were randomised to receive a six month course of Gingkco Biloba Extract (Tanakan) or matching placebo. Assessment, by claudication distance, A/B ratio, Doppler ankle pressure response to exercise together with recovery time, and a 10 cm analogue scale (LAS) estimation of maximal pain severity, was performed before treatment, and at 6, 12 and 24 weeks. LAS scores were significantly improved after 24 weeks in patients receiving EgB, but not placebo. Claudication distance was significantly increased by Egb. Although claudication distance also increased in the placebo group, this was not significant. A/B ratio and Doppler ankle responses to exercise did not show any significant change in either group at any time interval, nor did the post exercise recovery time. Gingkco Biloba Extract is a safe and effective method of improving walking distance and reducing pain severity in patients with intermittent claudication, although Doppler studies have failed to suggest any gross improvement in the perfusion of the ischaemic leg.

Double-Blind Method↗

Chronic iliac vein obstruction as a cause of venous claudication. A plethysmographic and isotope phlebographic study.

Chronic obstruction of the iliac vein may be followed by severe pain, tense swelling and cyanosis of the affected lower limb on exercise (venous claudication). Four patients with venous claudication were examined by strain gauge plethysmography and isotope phlebography. One patient had earlier undergone vein by-pass surgery and one caval ligation. All patients had anatomically abundant, but functionally insufficient cross-over and collateral circulation as the cause of the venous claudication symptom. The venous emptying rate was below normal in all the affected limbs; the venous capacity was low in both limbs in 2 of the 4 patients. It is concluded that in venous claudication isotope phlebography confirms occlusion of the iliac vein and the presence of abundant cross-over veins. The pathologically slow venous return demonstrated by plethysmography in the affected and occasionally also in the unaffected limb, results from the fixed resistance of the cross-over veins.

Adult↗

The effect of superficial femoral artery occlusion on the outcome of aortofemoral bypass for intermittent claudication.

This study was undertaken to evaluate the effects of untreated superficial femoral artery occlusion in patients undergoing aortofemoral bypass for intermittent claudication. In 56 patients at a mean follow-up time of 3.3 years, graft patency, treadmill walking tolerance, and ankle systolic pressure indices (ASPI) were compared in two groups of limbs: those with a patent superficial femoral artery and those with that vessel occluded. There was a high graft patency rate with no significant difference between the two groups. In limbs with a patent superficial femoral artery, 86% were completely relieved of claudication. However, in limbs with an occluded superficial femoral artery, only 26% were relieved of claudication. In limbs with a patent superficial femoral artery, the mean postoperative ASPI was 0.87 (SE +/- 0.22) compared with 0.61 (SD +/- 0.17) in limbs with an occluded superficial femoral artery. These results indicate that, in patients with combined superficial femoral artery occlusion and aortoiliac disease, revascularizing the deep femoral artery by aortofemoral grafting often does not achieve relief of claudication. There is a need for more effective hemodynamic discrimination of the relative contribution of proximal and distal occlusions.

Aorta, Abdominal↗

[Arterial claudication].

The authors recall that in their report presented to the 79th French Congress of Surgery (September, 1977), they included the results of 26,632 chronic obstructive arteriopathies, 49.8% of them at the intermittent claudication stage. Medical treatment was initially proposed in 27% of cases. The results were followed up in 1,660 patients. At term (8 years and more), there were good results in only one third of the patients, and 28% of the patients had to be operated on. Lumbar sympathectomy was practiced on an isolated basis in 35% of cases. At the cost of a minimal (0.7%) mortality rate, with improvement beyond eight years in 61.5% of patients, and only 19% having to undergo direct revascularization. Direct revascularization was proposed in 38% of cases. At the aorto-iliac stage, thrombo-endarterectomies and single and bi-lateral prothetic bridgings gave very similar results: a mortality rate of 3.4% on the average, with good results beyond eight years in 76.6% of patients. Direct revascularizations are practiced almost as often on the femoro-popliteal level for simple intermittent claudications. Mortality is low (1%), and the long-range results similar (76.4% of good results beyond 8 years), but the installation of a prothesis at the femoro-popliteal stage so often fails that it should not be done if the intermittent claudication is tolerable. Surgery plays a prime role in the treatment of claudications of arterial origin, a role that the success and the continuation of the good results, when applied under the proper conditions, amply justifies.

Adrenalectomy↗

[Pentoxifylline and intermittent claudication: critical analysis of clinical trials].

Drug utility in the treatment of intermittent claudication is controversial, mainly because of data heterogeneity and not too obvious benefit in the clinical trials. Pentoxifylline is the world's largest prescribed drug for intermittent claudication. In an attempt to define its benefit in the global care of the claudicants, we have analysed all the randomized double-blind, placebo-controlled trials listed from the international data-bases. Methodology of these trials have been compared with the European and FDA guidelines. In this respect, the 3 best suitable studies are consistent with one other and with a statistical benefit of pentoxifylline on the claudication distances. Although this effect is not truly predictive of the long term benefit-risk ratio of the drug, it seems clinically useful, especially when considering stable patients and when using the drug after previous physical training.

Clinical Trials as Topic↗

Influence of clinical resources on the treatment of intermittent claudication.

Management of intermittent claudication varies between surgeons, even after adjustment for case-mix, and could be related to the availability of clinical resources. The aim of this study was to ascertain whether vascular surgeons perceived deficiencies in the resources available to them for the management of claudication and to determine whether an association existed between reported deficits and patient management. Over a six month period, 28 vascular surgeons in Scotland completed recording forms on their treatment intentions for 1,180 claudicants. Subsequently, the surgeons were interviewed about resources available for vascular surgery. The majority of surgeons reported deficiencies in resources, predominantly insufficient operating lists (71%) and staff shortages (71%). Although considered less important than clinical factors or patient wishes, resources were independently associated with treatment. Surgeons reporting insufficient operating lists were less likely to opt for surgical treatment (p < 0.05), and those working with reluctant or inexperienced radiologists were less likely to consider percutaneous transluminal angioplasty (p < 0.05) and more likely to offer surgery (p < 0.001). However, case-mix and resources explained only some of the variations in treatment. The residual variation was likely to reflect an underlying lack of agreement among surgeons on the most appropriate management of claudication. Randomised controlled trials to address this issue would be welcomed by the majority of surgeons questioned.

Angioplasty, Balloon↗

Do patients with intermittent claudication need surgical treatment?

To determine whether surgical intervention is of therapeutic significance for patients with intermittent claudication (IC), 315 patients with IC followed in our outpatient clinics for the past 8 years 3 months (mean of 3 years 10 months), including 142 non-operated and 173 operated patients, were investigated as to changes in symptoms and the prognosis. Changes in symptoms in both groups were analyzed according to the variable distances of claudication and location of the diseased artery. To examine the degree of association between surgery and improvement of symptoms, Goodman and Kruskal's gamma was used. For all subgroups with a variable claudication distance (group A; distance < 100 m, B: 100-500 m, C: > 500 m), surgery inversely correlated with improvement in symptoms (group A; gamma = -0.378, group B; gamma = -0.651, group C; gamma = -0.828). According to location of the diseased artery, surgery correlated with improvement in symptoms in aorto-iliac (gamma = -0.811), aorto-ilio-superficial femoral (gamma = -0.641), and superficial femoral-distal (gamma = -0.533) groups but not in superficial femoral (gamma = -0.427) or infrapopliteal (gamma = -0.194) alone groups. Concerning the prognosis, no significant difference was noted between operated and non-operated groups (p = 0.35). These computed data show that surgical intervention has therapeutic significance for patients with IC, except for cases of claudication with segmental occlusion of the superficial femoral or infrapopliteal artery alone.

Aged↗

[Measurement of quality of life in intermittent claudication. Clinical validation of a questionnaire].

OBJECTIVES: Functional limitation in patients with intermittent claudication impairs their quality of life. In order to measure this new evaluation parameter, we developed a self-administered questionnaire: Artemis. METHODS: The questionnaire was composed of a general instrument (SF-36) and a specific one. A cross sectional study was performed in 177 patients with intermittent claudication (mean age 68 +/- 10 years, 77% males) who stated their walking distance was limited within 50 to + 2000 meters. The acceptability, reliability and sensitivity of the questionnaire were tested. RESULTS: In patients who had a walking distance greater than 500 m (n = 96), the scores obtained were significantly higher (better quality of life) than in patients whose walking distance was limited to less than 500 m (n = 81) (p < 0.05). Intermittent claudication had a global effect on the different parameters of the quality of life evaluated by the questionnaire including physical performance and psychological and social aspects. CONCLUSION: The Artemis questionnaire as shown its ability to describe patients with intermittent claudication. It can be used in clinical trials as a tool for measuring quality of life.

Activities of Daily Living↗

Asymptomatic carotid artery bifurcation disease in patients with claudication.

A study was undertaken to determine the prevalence of asymptomatic atherosclerotic carotid artery bifurcation disease in patients presenting with claudication; thus 263 consecutive patients with intermittent claudication, but without recent or old cerebrovascular symptoms were studied by routine carotid duplex scanning. Of the 263 patients, 124 (47.1%) had a C, D, D+ or E lesion in some vessels of the carotid bifurcation and 54 (20.5%) had a D, D+ or E lesion of the common or internal carotid arteries. Women had a higher prevalence of significant carotid stenosis (29.6% v. 18.2% in men) as did patients over the age of 70 years (28.6% v. 16.3% if below 70 years). It is concluded that the prevalence of clinically significant carotid bifurcation disease (greater than 50% stenosis in the common or internal carotid arteries) in patients with claudication is high (20.5%). The presence of an asymptomatic high-grade stenosis (D+ or E) in 11.8% of patients with claudication should alert the clinician that he is treating a patient who is at a high risk of developing cerebrovascular ischaemic complications.

Aged↗

A review of the clinical effectiveness of exercise therapy for intermittent claudication.

BACKGROUND: Intermittent claudication is both frequent and disabling. Conservative treatment consists of the elimination of risk factors, particularly smoking, drug treatment, and physical exercises. This review represents an attempt to define how effectively exercise prolongs the walking ability of claudicants. METHODS: A computerized literature search was done to identify all controlled trials on the subject. In addition, other studies were admitted if they were in accordance with certain quality criteria. RESULTS: Without exception, these studies showed that exercise can prolong the pain-free walking distance of claudicants. Even though this message seems uniform and convincing, one should point out that all trials are burdened with methodological flaws. The variability of increase in walking ability demonstrated in these studies is impressive and cannot be fully explained. A multitude of possible mechanisms could be involved in bringing about the clinical effect; at present it is impossible to define their relative importance. CONCLUSIONS: The optimal exercise program should be supervised, performed regularly for at least 2 months, and of high intensity. Appropriate steps to guarantee patients' compliance must be taken. Even though many fundamental questions remain unanswered, it is justified to prescribe exercise therapy for intermittent claudication more generally than is realized in today's practice.

Clinical Trials as Topic↗

Hydrotherapy of patients with intermittent claudication: a novel approach to improve systolic ankle pressure and reduce symptoms.

OBJECTIVE: To study the effects of alternating cold and hot water therapy on walking ability and systolic blood pressure in claudicants. EXPERIMENTAL DESIGN: A prospective case study with repeated measurements before and 1, 4 and 12 months after treatment. The systolic blood pressure levels were measured with an occlusion cuff for brachial and ankle and with a strain gauge for the first toe. STUDY POPULATION: Twenty consecutively included patients, 11 women and 9 men; mean age 73.9 yrs, with intermittent claudication according to clinical examination and ankle-arm systolic blood pressure (AAI) below 0.90. INTERVENTION: Alternate hot and cold hydrotherapy of the legs were given at ten 25-minute treatments during a three-week period. The outcome measures were maximal walking ability (MW), walking ability before pain (PW) and systolic blood pressures of toe, ankle, arm and AAI. RESULTS: Fourteen patients (70%) reported reduced pain after treatment and their PW increased from 134 +/- 29 m to 415 +/- 119 m 12 months later (p < 0.05) and the MW in the total group increased form 348 +/- 75 m to 523 +/- 103 m. Systolic blood pressure increased in right ankle and toe one month after treatment in the total group. Among those who reported improved walking ability one year after treatment, systolic blood pressure in both right and left ankles and toes increased; e.g. right toe increasing from 72 +/- 7 to 86 +/- 2 (p < 0.001). Improvements of systolic blood pressure in left and right leg and changes of walking ability were correlated, in the order of 0.60 to 0.81, p < 0.05. CONCLUSIONS: Showering the legs of claudicants improved walking ability and blood pressures which sustained up to 1-year later. This therapy might be an additional alternative to conservative treatment of intermittent claudication.

Aged↗

Neuromuscular disorders in patients with intermittent claudication.

OBJECTIVE: To evaluate the effect of claudication on nerve function in patients with unilateral peripheral arterial disease. DESIGN: Prospective study. SETTING: District hospital, The Netherlands. SUBJECTS: 11 Patients with unilateral intermittent claudication (diagnosed from history and ankle-brachial blood pressure index) underwent electrophysiological studies of both legs, including nerve conduction velocities, motor unit action potentials, H-reflex measurements, and muscle strength testing. The asymptomatic leg was used as the control in each case. RESULTS: Six patients had neuropathy in both the claudicating and the control leg. Three other patients had neuropathy in the claudicating leg only, which consisted mainly of disorders of nerve conduction including the H-reflex. There was no clear difference between muscle strength in the symptomatic and control legs, possibly because more than half the patients studied, had neuropathy in both legs. CONCLUSIONS: Neuropathy is common at an early stage of arterial disease and could be one of the factors leading to impaired muscle function in such patients.

Action Potentials↗

[Personality traits (type A) in patients with intermittent claudication. 1. Results of the Bortner test].

It has never been considered whether type A (coronary prone) behavior can also be found in patients with peripheral atherosclerotic disease (intermittent claudication). This question has been studied by means of the 14-item (Bortner) questionnaire. The questionnaire was filled out by 10 patients (self-assessment) with coronary artery disease and intermittend claudication, 13 with intermittent claudication alone and 10 with comparably severe, but not arteriovascular disease and independently by their wives (relative's assessment). In the self-assessment the test discriminated significantly between the three groups (Kruskal-Wallis p less than 0.05). The correlation coefficient (Spearman) between expression of type A behavior and extent of atherosclerosis was 0.3720 (p less than 0.02). In the relative's assessment the groups were also differentiated significantly (Kruskal-Wallis p less than 0.05). The correlation coefficient (Spearman) was 0.4080 (p less than 0.009). The results indicate that patients with intermittent claudication demonstrate a predilection for type A behavior, which is more pronounced in those with additional coronary artery disease. The multiple stepwise regression indicated that type A behavior is related to atherosclerosis independently of other factors.

Coronary Disease↗

[Transient radicular nerve conduction block in patients with intermittent neurogenic claudication].

Patients with neurogenic claudication do not usually exhibit symptoms at rest. The diagnosis is uncertain when there are no signs of lumbar radiculopathy. However, the functional deficiary could show up during a brief time at presentation of the symptoms if appropriate electrophysiological techniques are used to measure nerve conduction at the radicular segment. In 8 patients with neurogenic claudication, we examined the curve of recruitment of the soleus H reflex and in four of them the chronodispersion of the F wave of the posterior tibial nerve, before and after walking was also examined. Both studies showed normal results before walking in all patients. The H wave showed a transient diminution of excitability in 6 patients after walking, which lasted for a mean period of 7 min. Only one of these patients also showed an increase in the chronodispersion of the F wave. Our data suggest that conduction is transiently blocked in large myelinated fibers at a radicular level in patients with neurogenic claudication after walking. This could partially explain the symptoms of neurogenic claudication.

Adult↗

Lipoprotein (a) and development of intermittent claudication and major cardiovascular events in men and women: the Edinburgh Artery Study.

Lipoprotein (a) may be an important risk factor for atherosclerosis. It is widely accepted that lipoprotein (a) levels are raised in patients with coronary heart disease, but there is some doubt about the causality of the relationship. In addition, little is known about the relationship between lipoprotein (a) and either stroke or peripheral arterial disease, nor about the role of lipoprotein (a) in women. Subjects aged 55-74 years (n=1592) were selected at random from 11 general practices in Edinburgh, Scotland and followed up for 5 years. The incidences of myocardial infarction, intermittent claudication and stroke were 13.4, 9.4 and 3.7%, respectively. Raised lipoprotein (a) levels at baseline were associated with an increased risk (95% confidence interval) of myocardial infarction RR 1.15 (1.00, 1.32), intermittent claudication RR 1.32 (1.10, 1.57) but not significantly for stroke RR 1.24 (0.93, 1.64). This increased risk persisted for intermittent claudication after adjustment for baseline cardiovascular disease and other risk factors RR 1.20 (1.00, 1.43), but for myocardial infarction became non-significant RR 1.06 (0.91, 1.23). The risk of disease associated with raised lipoprotein (a) was slightly higher in women than in men, especially for intermittent claudication (men RR 1.09 (0.87, 1.36) compared to women RR 1.37 (1.01, 1.87)). In conclusion, we found that lipoprotein (a) was an independent predictor of cardiovascular events in both sexes. The association between lipoprotein (a) and cardiovascular events may have been stronger in women than in men, and for peripheral arterial disease than myocardial infarction and stroke.

Aged↗

Hypogastric artery coil embolization prior to endoluminal repair of aneurysms and fistulas: buttock claudication, a recognized but possibly preventable complication.

PURPOSE: Hypogastric artery embolization is considered to be necessary to prevent retrograde flow and potential endoleaks when a stent-graft crosses the origin of the hypogastric artery. The authors assess the incidence of buttock claudication, which is the primary complication encountered. The effect of coil location and the presence of antegrade flow at the completion of embolization are evaluated. MATERIALS AND METHODS: Hypogastric artery embolization and endoluminal repair of aneurysms and fistulas was performed in 34 patients (30 men; four women) aged 27-91 years (mean, 76 years). Ten patients were being treated for solitary abdominal aortic aneurysms, 13 were being treated for aortoiliac aneurysms, and six patients were being treated for isolated common iliac aneurysms, three for hypogastric artery aneurysms and two for iliac arteriovenous fistulas. Eleven patients had coils placed completely above the bifurcation of the hypogastric artery and 23 patients had coils placed at the bifurcation, or within the branches of the hypogastric artery. Preservation of antegrade flow after embolization was noted in 14 of 34 patients. RESULTS: Thirty-four patients underwent stent-graft repair after hypogastric artery embolization. There were two perioperative deaths, three proximal leaks, and one collateral leak. Of the 32 patients who survived the procedure, there was one retrograde leak, even though 13 of 32 (41%) patients had continued antegrade flow at completion of the hypogastric artery embolization. When coils were placed at or in the bifurcation of the hypogastric artery, 12 of 22 (55%) experienced claudication. When coils were placed in the proximal hypogastric artery, one of 10 (10%) claudicated. CONCLUSION: It is probably not necessary to completely occlude antegrade flow in the hypogastric artery to prevent a distal endoleak. Buttock claudication is rare when coils are placed in the proximal hypogastric artery rather than at its bifurcation or in its branches.

Adult↗

Vascular surgical society of great britain and ireland: prospective randomized double-blind placebo-controlled crossover study to assess the effect of sublingual glyceryl trinitrate in patients with intermittent claudication

BACKGROUND: The effect of sublingual glyceryl trinitrate (GTN) on the claudication distance (CD) and maximum walking distance (MWD) of patients with intermittent claudication was assessed. METHODS: Inclusion criteria were: history of intermittent claudication; resting ankle : brachial pressure index (ABPI) of 1.00 or less; fall in ABPI of more than 0.1 following exercise; and patient not taking nitrates. In the first study 22 patients (median age 69 (range 60-73) years, 16 men, five diabetic, median resting ABPI 0.57 (range 0.1-0.64)) had their CD and MWD measured on a treadmill set at 3.2 km h-1 and 10 per cent gradient. They were then randomized to either GTN or placebo spray, and the distances were remeasured. The crossover portion of the study was then completed. In the second study 28 patients (median age 68 (range 45-84) years, 20 men, six diabetic, median resting ABPI 0.57 (range 0.13-0.98)) were randomized to either GTN or placebo and walked at their own pace along a flat corridor for 15 min. Following a rest of 15 min, the crossover portion of the study was completed. Statistical analysis was by the Wilcoxon matched pairs signed rank test. RESULTS: CONCLUSION: GTN can increase the MWD by 19 per cent when patients with intermittent claudication are walked on a treadmill and by 9 per cent when walking at their own pace on a flat gradient.

Journal Article↗

Vascular surgical society of great britain and ireland: angioplasty reverses the systemic effects of exercise in intermittent claudication

BACKGROUND: The choice between exercise training and percutaneous transluminal angioplasty (PTA) in the treatment of intermittent claudication (IC) remains controversial. Exercise is known to induce systemic effects in claudicants. This study aimed to determine whether such systemic effects are reversed by PTA. METHODS: Ten patients with IC were recruited before PTA. Having emptied the bladder and rested for 1 h, pre-exercise blood and urine samples were collected. Patients underwent treadmill exercise to their maximum walking time and further blood samples were collected at 10, 20 and 30 min. A second urine sample was collected at 60 min. Total antioxidant capacity (TAC) and von Willebrand factor (vWF) were measured in blood, and albumin : creatinine ratio (ACR) and retinol binding protein : creatinine ratio (RBP : Cr) in urine. Patients were recalled 2 weeks after successful angioplasty and the protocol was repeated. Statistical analysis was by Wilcoxon signed rank test. RESULTS: Following PTA, all patients walked for 5 min on the treadmill. All patients had a significant exercise-induced fall in ankle pressure that was reversed by PTA. Changes in TAC are shown in the Table. There was no significant change in vWF. Exercise in claudicants induced a significant increase in median ACR (pre/post exercise (pre-exercise value divided by post-exercise value) 0.8; P = 0.03) and in median RBP : Cr (pre/post exercise 1.8; P = 0.04). These changes were no longer evident after successful PTA. CONCLUSION: Exercise-induced changes in renal glomerular (ACR) and tubular function (RBP : Cr) in claudicants were reversed by successful angioplasty. PTA reduced the systemic TAC before and after exercise suggesting a reduced free radical challenge.

Journal Article↗